TECHNOLOGY

WHAT IS DIRECT EFFECTS?

What is Direct Effects?

Direct Effects™ Topical Drug Therapy is a novel approach to deliver neuro-active drugs directly into nerve tissue bypassing traditional means of absorption, distribution and excretion.  This technology may result in lower drug exposure, increased delivery to target sites and decreased potential for side effects and drug interactions.

Current therapies usually require oral entry, injection, or transdermal patch to achieve a therapeutic blood level. In the case of oral administration the drug must be absorbed through the gastro-intestinal system, metabolized by the liver and/or kidneys, distributed through the vascular system and eventually find its way to the targeted tissue in the brain. Presence of the “blood-brain-barrier” prevents many drugs from effectively reaching target sites in the brain. While some may reach the brain in small amounts, others are unable to cross the barrier altogether. As Direct Effects works through direct nerve connections without involvement of blood, this is not an issue with drugs delivered in this way.

It is further believed that many reported adverse reactions caused by the administration of neuro-active drugs are due to systemic distribution of the agent to non-targeted sites throughout the body.

It is these unwanted adverse events and side effects that limit the effectiveness and tolerability of many of these drugs in consumer use.

Replacing oral and other systemic routes of administration, the Direct Effects™ Topical Drug Therapy is believed to work by penetrating peripheral nerve endings providing a direct avenue to neural tissue within the brain.  It is the proliferation of nerve endings close to the surface of the skin at the back of the neck that provides the conduit for success with the Direct Effects™ Topical Drug Therapy.

The use of the Direct Effects™ Topical Drug Therapy has in observational data provided therapeutic benefit and no systemic adverse effects when using many different active drugs.  This has been accomplished with a fraction of the normally required dose.

POTENTIAL ADVANTAGES

So why is Direct Effects a better solution?

Direct Effects™ improves effectiveness of an active drug –

For drugs with high activity but poor distribution, Direct Effects follows natural nerve pathways to the target tissue allowing for smaller doses and symptom relief in minutes, instead of hours.

Direct Effects™ vastly reduces side effects –

Most side effects from traditional drug delivery results from drug’s impact on non-targeted tissue. Direct Effects does not distribute throughout body vastly reducing exposure to drug toxicities.

Direct Effects™ has a rapid onset –

The use of the Direct Effects™ Topical Drug Therapy has shown symptom reduction in as little as 10-15 minutes in Parkinson’s Disease, Migraine Headache, Analgesia and Muscle Spasticity using a variety of currently available pharmacologic agents.  Oral administration of these same drugs can take hours or even days to achieve pharmacologic actions.

Direct Effects™ enhances overall efficacy –

Anecdotal and observational data have shown impressive results in reducing tremors, rigidity and other standard metrics in Parkinson’s disease.  Substantial reductions in pain scores and other neurological symptoms have been observed in migraine headache patients.  Vast reductions in muscular rigidity have been noted with the use of the system in muscular spasticity.  These effects will be quantified and stratified as the system is further studied through traditional clinical trials.

Direct Effects™ reduces adverse effects –

It is logical that avoiding systemic exposure to a neuro-affective agent would reduce adverse events.  Experience with the Direct Effects™ Topical Drug Therapy has so far produced targeted symptom reduction without significant adverse events.  This advantage is believed to hold promise not only by improving the overall quality of life of patients exposed to such agents but also by making many drugs available that are currently limited by tolerability of their systemic adverse effects.

Direct Effects™ reduces total dose exposure –

The ideal pharmacologic agent would use only the minimum amount of drug necessary to achieve the targeted effect.  With oral and intravascular administration of drugs this is not possible due to the normal functions of absorption, metabolism, distribution and excretion.  In traditional drug administration non-targeted tissue can be impacted often resulting in unwanted side-effects. In some cases, the drug can even become toxic to non-targeted tissue resulting in long term damage to the body.  Further, the excretion of pharmacologic agents has been found responsible for increasing levels of toxins in our water supply.  The Direct Effect’s™ Topical Drug Therapy is believed to introduce the neuro-affective agent directly into nerve tissue resulting in much lower dosing and possibly eliminating or vastly reducing excreted drug components.